RICROKERATOME BLADE

{0}------------------------------------------------ NOV I 6 1999 Surgistar Inc. Microkeratome Blade K992978 November 1, 1999 510k No. K992978 ## 510(K) Summary (As required by 21 CFR 807.92) Page 1 of 3 # Submitter: Surgistar, Inc. 6068 Corte Del Cedro Carlsbad, CA. 92009 ## Contact person: Jonathan Woodward #### Telephone: (760) 431-7400 Fax: (760) 431 6768 | Trade name: | Surgistar Microkeratome Blade | |----------------------|-------------------------------| | Common name: | Microkeratome Blade | | Classification name: | Microkeratome Blade | ### Legally marketed device to which we are claiming equivalence: Chiron Vision Corp Automatic Corneal Shaper Surgical Instrument (BLADE ONLY) 510(k) Number - K941550 #### Description of the Device: Replacement Stainless Steel Blade for Chiron Automatic Corneal Shaper Blade Intended use of the device: Replacement Blade for Chiron Automatic Corneal Shaper Blade {1}------------------------------------------------ Surgistar Inc. Microkeratome Blade November 1, 1999 510k No. K992978 Page 2 of 3 Summary ## Summary of Technological characteristics of device compared to predicate device.(Section 807.92(a)(6) | CHARACTERISTICS | AUTOMATIC CORNEAL SHAPER BLADE<br>ONLY(PREDICATE-) | Surgistar<br>MICROKERATOME<br>Prod No. 2200 | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | INTENDED USE | FOR PERFORMING LAMELLAR RESECTIONS OF<br>THE CORNEA | SAME | | OPERATION<br>PRINCIPLE | BLADE IS HELD IN ELECTRICALLY DRIVEN<br>OCILLATING HEAD (PROVIDED BY ORIGINAL<br>EQUIPMENT MANUFACTURER Eg CHIRON)<br>WHICH GUIDES BLADE ACROSS CORNEA | SAME | | PATIENT CONTACT<br>PORTION OF DEVICE | BLADE | SAME | | MATERIALS | LOW CARBON STAINLESS STEEL | SAME | | STERILIZATION<br>METHOD (BLADE) | EO | RADIATION-GAMMA | {2}------------------------------------------------ #### Page 3 of 3 Summary # DIMENSIONAL & SHARPNESS EQUIVALENCY CHART | ATTRIBUTE | CHIRON ACS<br>BLADE<br>AS MEASURED | SURGISTAR<br>MICRO KERATOME BLADE<br>SPECIFICATION | |-------------------------|------------------------------------|----------------------------------------------------| | LENGTH | 0.448" | 0.445" +/- .005 | | WIDTH | 0.313" | 0.313" +/- .003 | | THICKNESS | 0.0102" | 0.010" +/- .0003 | | BEVEL | 11 TO 12.5 DEG | 11.5 Deg +/- 1 Deg | | MOUNTING<br>HOLE LENGTH | 0.2805 | 0.2805 +/-.0005 | | MOUNTING<br>HOLE WIDTH | 0.0866 | 0.0866 +/-.0005 | | MOUNTING<br>HOLE RADIUS | 0.0433 | 0.0433 +/-.0005 | | SHARPNESS* | 4 to 7 OZ | 5.5 OZ +/- 1.5 OZ | * As measured in ounces of force. At Will (Signature) Jonathan Woodward (Typed Name) November 1,.1999 K 992978 (Premarket Notification [510(k)] Number) {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV I 6 1999 Mr. Jonathan Woodward President Surgistar, Inc. 6068 Corte Del Cedro Carlsbad, CA 92009 Re: K992978 Trade Name: Microkeratome Blade Regulatory Class: I Product Code: 86 HNO Dated: October 13, 1999 Received: October 14, 1999 Dear Mr. Woodward: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations . {4}------------------------------------------------ Page 2 - Mr. Jonathan Woodward This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page 2 of 5 510(k) Number (if known):__K 992978 SURGISTAR MicroKeRTome BLADE Device Name:_ Indications For Use: #### Statement of indication for use The Surgistar Microkeratome is indicated for use as a replacement blade in the Chiron Vision Automatic Corneal Shaper Surgical Instrument (ACS). The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Jas Calloway (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K992978 Prescription Use_v (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)